NICE Recommends AstraZeneca’s Calquence (Acalabrutinib) for CLL Treatment in NHS

Compiled by Fan Dongdong

Recently, the UK’s National Institute for Health and Care Excellence (NICE) decided to recommend AstraZeneca’s BTK inhibitor Calquence (acalabrutinib) for inclusion in the UK National Health Service (NHS) for the treatment of certain adults with chronic lymphocytic leukemia (CLL). As a result, this drug has become the first targeted oral therapy for UK patients with chronic lymphocytic leukemia (CLL) who cannot be treated with first-line chemotherapy.

According to the draft guidelines issued by UK regulators, the drug was approved last December as monotherapy for patients with chronic lymphocytic leukemia (CLL) harboring 17p deletion or TP53 mutations, or for those with CLL for whom fludarabine in combination with cyclophosphamide and rituximab (FCR), as well as bendamustine in combination with rituximab (BR), are unsuitable. Experts participating in the NICE Medicines Advisory Committee also emphasized that, compared with current treatment modalities for CLL, Calquence demonstrates favorable tolerability and a lower incidence of adverse effects.

Calquence’s recommendation by the UK’s NICE will provide a new treatment option beyond chemotherapy for this patient population, which is particularly beneficial during the COVID-19 pandemic, as patients often find it inconvenient to make frequent hospital visits due to the outbreak. Currently, the list price for a 30-day supply of 100 mg Calquence tablets is £5,059 (approximately RMB 45,766). However, AstraZeneca will sell the drug to the UK NHS at a discounted price based on this list price.

Last November, the European Medicines Agency (EMA) approved Calquence as a monotherapy or in combination with Roche’s Gazyvaro (obinutuzumab) for the treatment of patients with previously untreated and relapsed or refractory chronic lymphocytic leukemia (CLL). The UK’s National Institute for Health and Care Excellence (NICE) stated, “No recommendations were made regarding the comparative effectiveness of acalabrutinib versus obinutuzumab, as the company did not submit any data on this combination.”

Reference Source:

1.NICE backs AstraZeneca’s Calquence for CLL

2.NICE backs AZ’s Calquence for new use in leukaemia

3.NICE backs AstraZeneca’s Calquence for CLL